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Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism (T4-T3)

This study has been completed.
Information provided by:
Copenhagen University Hospital at Herlev Identifier:
First received: September 18, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy

Condition Intervention Phase
Quality of Life
Drug: Triiodothyronine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.

Resource links provided by NLM:

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Selv-rating scales: SF-36, SCL -90-R, BDI [ Time Frame: 3 month treating ]

Secondary Outcome Measures:
  • BMI, bioimpedance [ Time Frame: 3 month treament ]

Enrollment: 59
Study Start Date: April 2003
Study Completion Date: March 2007
Arms Assigned Interventions
No Intervention: 1
Usual T4 dose is given
Active Comparator: 2
20 microgram of T3 is given and 50 microgram of T4 is withdrawn
Drug: Triiodothyronine
50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

Detailed Description:
double blind randomized cross-over study.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6 months.

Exclusion Criteria:

  • <18 år
  • >75 år
  • pregnant women
  • Thyroid cancer
  • T3 treatment
  • Post-partum thyroiditis
  Contacts and Locations
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Please refer to this study by its identifier: NCT00531713

Dept of endocrinology , Herlev Hospital
Herlev, Denmark, dk-3650
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Principal Investigator: Birte Nygaard Herlev Trials
  More Information Identifier: NCT00531713     History of Changes
Other Study ID Numbers: T4-T3 hypothyreose
KA 02022ms
Study First Received: September 18, 2007
Last Updated: September 18, 2007

Keywords provided by Copenhagen University Hospital at Herlev:
hypothyroidism, quality og life, depression

Additional relevant MeSH terms:
Behavioral Symptoms
Thyroid Diseases
Endocrine System Diseases processed this record on May 25, 2017